Monoclonal Antibodies and Fc‐Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration-Reference-Cited by-同舟云学术

Monoclonal Antibodies and Fc‐Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration

Published:2019-03-13 Issue:8 Volume:59 Page:1130-1143
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Liu Xiaomei I.¹²,Dallmann André³,Wang Yow‐Ming¹,Green Dionna J.⁴,Burnham Janelle M.¹,Chiang Beatrice⁵,Wu Perry⁵,Sheng Mark⁵,Lu Kelley⁶,Anker John N.²³,Burckart Gilbert J.¹

Affiliation:

1. Office of Clinical PharmacologyCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring MD USA

2. Children's National Medical Center Washington DC USA

3. Pediatric Pharmacology and Pharmacometrics Research CenterUniversity Children's Hospital Basel (UKBB) Switzerland

4. Office of Pediatric TherapeuticsCommissioner's OfficeUS Food and Drug Administration Silver Spring MD USA

5. School of PharmacyUniversity of Southern California Los Angeles CA USA

6. College of PharmacyUniversity of Texas Austin TX USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1406

Reference89 articles.

1. US Food and Drug Administration.Immunogenicity Assessment for Therapeutic Protein Products.https://www.fda.gov/downloads/drugs/guidances/ucm338856.pdf. Accessed January 31 2019.2014.

2. US Food and Drug Administration.Guidance for Industry: Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti‐Drug Antibody Dectection.https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm629728.pdf. Accessed on January 31 2019.2019.

3. Pharmacologic target-mediated drug disposition

4. The In Silico Child: Using Simulation to Guide Pediatric Drug Development and Manage Pediatric Pharmacotherapy

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